MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY FORTILINK-C IBF SYSTEM; INTERBODY FUSION DEVICE

Model Number	65-C-1517-7-6L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiac Arrest (1762)
Date of Event	06/25/2024
Type of Reportable Event	Death
Event or Problem Description
A 4-level acdf procedure was completed successfully and during the flip of the patient a cardiac arrest event happened and the patient expired.It was confirmed that this was not a product related event.
Additional Manufacturer Narrative
The anterior/acdf was completed with no complications.As the superficial would was being closed the patient coded.The patient was revived.The posterior portion of the procedure needed to be completed.It was believed that the patient threw a pulmonary embolus while in the process of being turned over from anterior to posterior, and the patient was not able to be revived.There is no allegation against the device.
Additional Manufacturer Narrative
This follow up is to correct the udi number that was incorrectly entered on the initial report.The anterior/acdf was completed with no complications.As the superficial would was being closed the patient coded.The patient was revived.The posterior portion of the procedure needed to be completed.It was believed that the patient threw a pulmonary embolus while in the process of being turned over from anterior to posterior, and the patient was not able to be revived.There is no allegation against the device.
Event or Problem Description
A 4-level acdf procedure was completed successfully and during the flip of the patient a cardiac arrest event happened and the patient expired.It was confirmed that this was not a product related event.

• Brand Name: FORTILINK-C IBF SYSTEM
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer Contact: katie moyle ; 375 river park circle; marquette, MI 49855 ; 9062255620
• MDR Report Key: 19964929
• Report Number: 1833824-2024-41504
• Device Sequence Number: 8962543
• Product Code: MAX
• UDI-Device Identifier: 00191083006727
• UDI-Public: (01)00191083006727(17)270524(10)423423
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K192718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 65-C-1517-7-6L
• Device Catalogue Number: 65-C-1517-7-6L
• Device Lot Number: 423423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown